We are looking for a CSV Consultant with 5+ years of experience in Computer System Validation within a GxP-regulated setting. The consultant will ensure that computerized systems comply with applicable regulatory requirements and industry standards.

Key Responsibilities:

- Prepare and review validation documents, including URS, risk assessments, validation protocols, test scripts, and validation summary reports.
- Execute CSV activities in accordance with GxP requirements and company SOPs.
- Ensure compliance with FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and data integrity principles (ALCOA+).
- Support IQ/OQ/PQ, UAT, defect management, deviation handling, and change control activities, as applicable.
- Perform validation impact assessments and maintain requirements traceability.
- Collaborate with IT, Quality Assurance, and business teams to ensure audit readiness.

Required Skills:

- Hands-on experience in CSV within pharmaceutical or life sciences environments.
- Knowledge of GxP regulations, risk-based validation, and SDLC.
- Experience with validation documentation and testing tools such as HP ALM, Qtest, Jira and Veeva QMS.
- Strong documentation, analytical, and communication skills.

📌 Validation consultant (Bengaluru)
🏢 CygnusPro Software Solutions Private
📍 Bengaluru